Status:
COMPLETED
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo. The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
Detailed Description
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age\>40 years
- History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
- Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) \<0.8 or Systolic ankle pressure (AP) \< 50 mmHg or Systolic toe pressure \<50 mmHg
- Patent femoral inflow above the level of injections recently (\<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
- Exclusion criteria:
- Evidence of other causes for leg pain other than intermittent claudication.
- Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
- Pain at rest
- Buerger's disease
- Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
- Subjects with serum creatinine \> 2 mg/dl (176 µmol/l) and subjects on dialysis.
- Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
- Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
- Previous treatment with any angiogenic growth factor
- Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
- Serious concomitant medical conditions not adequately controlled.
- Current alcohol or drug abuse
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01157871
Start Date
June 1 2004
End Date
August 1 2005
Last Update
July 7 2010
Active Locations (4)
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1
Minneapolis, Minnesota, United States
2
Brussels, Belgium
3
Münster, Germany
4
Bern, Switzerland